Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05986682
• Other study ID #: Pro00110976
• Secondary ID: 218855
• Status: Completed
• Start date: September 18, 2023
• Est. completion date: November 7, 2023

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf (BLENREP) and associated patterns of care, including dosing and dose modification, eye care specialist visits, associated healthcare utilization, and clinical outcomes in patients with relapsed and/or refractory multiple myeloma (RRMM) seen in the Duke Cancer Institute (DCI) clinics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Age > 18 years of age as of start of treatment with BLENREP
• Patients with a corresponding diagnosis code consistent with multiple myeloma seen at Duke.
• Patients with a record of starting treatment with BLENREP for RRMM between August 5, 2020 and November 22, 2022.
• Patients having healthcare encounters at Duke Cancer Institute (DCI) for at least 1-month after start of Blenrep treatment.

Exclusion Criteria:

• Patients who were included in any clinical trial for BLENREP including expanded access clinical trials
• Age > 89 years of age as of start of index therapy

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Blenrep
Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment characteristics of BLENREP therapy	Treatment use and treatment patterns (dose, length of treatment, delays and dose reductions, reasons for discontinuation) will be summarized using proportions.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Treatment characteristics: Dosing patterns - Delays in treatment with BLENREP therapy	Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Treatment characteristics: Dosing patterns - Dose reductions during treatment with BLENREP therapy	Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Treatment characteristics: Duration of treatment with BLENREP	Time (number of days) elapsed from treatment initiation with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation[SD]) and median (with interquartile range [IQR]) will be used to summarize duration across participants.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Treatment characteristics: Number of cycles of treatment with BLENREP	Number of cycles of treatment with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation[SD]) and median (with interquartile range [IQR]) will be used to summarize duration across participants.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Treatment characteristics: Discontinuation of BLENREP treatment	Number of participants who discontinued treatment with BLENREP by reason.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Clinical outcomes: Overall Survival (OS)	The time from the start of BLENREP treatment until death, with censoring of participants who were alive when last seen or who were lost to follow up.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Clinical outcomes: Overall Response Rate (ORR)	The percentage of participants with the best overall response: partial response (PR), very good partial response (VFPR), compete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group [IMWG] response criteria (if available) or clinician assessment.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Clinical outcomes: Progression-Free Survival (PFS)	The time from the start of BLENREP treatment until the earliest of documented disease progression (according to IMWG response criteria or clinician assessment), end of BLENREP treatment, death, lost to followup or end of study timeframe.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Clinical outcomes: Time To Response	The time from the start of BLENREP treatment to the date of first occurrence of response.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Primary	Clinical outcomes: Duration of Response	The time from the first date of PR or better to the earliest of documented disease progression, end of BLENREP treatment, death, lost to followup or end of study timeframe.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Secondary	Ophthalmology visits	a. The number of eye exam visits during BLENREP treatment.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Secondary	Ophthalmology: Presence of Ocular toxicity	Number of participants with specific ocular adverse events of interest (e.g. keratopathy) during treatment with BLENREP	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Secondary	Ophthalmology: Treatments for Ocular toxicity	Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Secondary	Magnitude of distress using National Comprehensive Cancer Network Distress Thermometer (NCCN DT)	Distress is measured on a scale of 0-10 on the NCCN DT. The main outcome variable is the occurrence of actionable distress, defined as a NCCN DT score of 4 or higher. The analysis will describe the proportion of clinic visits where actionable distress is reported during treatment with BLENREP, and the frequency of actionable distress over time.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Secondary	Sources of distress using NCCN DT	Sources of distress will be assessed using the NCCN DT Problem List by examining the proportion of visits where types of problems are reported (e.g., physical or emotional problems). The frequency of individual types of problems, and the most commonly-reported problems will be examined descriptively.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Secondary	Healthcare resource utilization (HCRU)	To the extent that they are available, HCRU (i.e., inpatient admissions, treatment-related outpatient visits, and emergency department visits) will be summarized by the mean (± SD) and median (with IQR) number of events per patient per year and by the proportion and frequency distribution of patients with any occurrence of the respective outcome. Likewise, mean (± SD) and median (with IQR) length of stay per year will be summarized for inpatient visits.	Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.